Priority Review for Stemline's blood cancer therapy

Stemline Therapeutics Inc. (NASDAQ:STML) said FDA accepted and granted Priority Review to its BLA for Elzonris tagraxofusp (SL-401) to treat blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare form of acute myelogenous leukemia (AML). Its PDUFA date is Feb. 21, 2019.

There are no approved treatments for BPDCN. Elzonris is an IL-3 receptor α (CD123)-targeting agent linked to a truncated diphtheria toxin payload. It has breakthrough therapy designation in the U.S. and Orphan Drug designation in the U.S. and EU to treat BPDCN...